The Clinical Trials Office - Online Submission

For Industry-Sponsored Clinical Trials

Submitting your proposal materials to the Clinical Trials Office has never been easier! Submission process, forms, and instructions are now available online.

Returning to the Online Submission Process? Click here to go directly to the online submission process forms. You will need your UNI and password to access these forms.

If you prefer to complete the submission materials on paper, the CTO Submission Package, which contains instructions and forms, is also available in Microsoft Word. Click here to download the Submission Package

New: Western IRB multi-center trial submission instructions Click here.

Submission Procedure Overview

Submission of CTO Required Documents
Submission of Sponsor Documents
CTO Review Process

•	The CTO must be notified of a pending trial as soon as the investigator begins to work with the industrial sponsors. Clinical investigators are requested to call the CTO and discuss projects as soon as possible.
•	All RASCAL proposal data sheets must be entered into the RASCAL online program; select Clinical Trials to enter your proposal information. Investigators should create a RASCAL proposal and enter associated proposal information online at: https://www.rascal.columbia.edu/props/ptframe.html
•	The Proposal Data must reflect an updated Conflict of Interest, HIPAA Compliance, and GCP certification for each individual involved in the study trial, including clinical research coordinators.
•	The IRB submission is also completed via the RASCAL system at: https://www.rascal.columbia.edu/comply/irbframe.html
	As an exception to the policy of submitting all protocol to the Columbia IRB, protocols and associated documents for Novartis, Amgen/Immunex, or Genentech protocols should be submitted directly to the CTO.
•	All other contractual documents must be submitted to the CTO no later than proposal/project submission to the Institutional Review Board (IRB)

Please note! The study cannot begin until IRB approval has been received and the contract has been executed.

Submission of CTO Required Documents

The Clinical Trials Office requires submission of the following documents to complete your proposal application. Click on the form name to begin the online submission process. Please note! You will need a valid UNI and password to access the online forms.

Departmental Chairs: click here to review and agree to the Compliance Statement.

The Clinical Trials Office has established a dedicated Help Desk for online submissions at 212-305-9517.

1.  Compliance Statement (Preview form)
The Compliance Statement provides information regarding investigator and departmental liability, and includes the Hospital and University expectations for accounting responsibilities. Both principal investigator and her/his departmental chairperson must agree to the Compliance Statement before the submission process is completed.

2.  Tax Exemption Certification (Preview form)
The Tax Exemption Certification indicates the relevance of the proposed clinical research to the advancement of the educational and scientific clinical research missions of the University and Hospital and its importance in the promotion of the health of the public. This information is then used to assure our tax-exempt status and as an aid in dispute resolution.

3.  Questionnaire (Preview form)
The Questionnaire form collects an information synopsis from the protocol. The CTO uses this information to identify areas that may need special consideration during the contracting process.

4.  Research Pharmacy Cost Estimate Request Form (Preview form)
The Research Pharmacy Cost Estimate Request form allows the Research Pharmacy to provide investigators with a more accurate estimate of costs associated with the procurement and distribution of pharmaceuticals. If your proposal does not require Research Pharmacy assistance, e.g., testing of a new medical device, continue to the Budget Worksheet and instructions for budget preparation. Please note: investigators requiring cost estimates from the New York State Psychiatric Institute’s Research Pharmacy should call the Contracts Department at (212) 305-3360.

5.  Budget Worksheet and Instructions (Preview form)
The CTO Finance department must approve all budgets prior to contract execution. The budget worksheet and instructions are provided as a guide to improve discussions with this department. The CTO Finance Budgets team members are continually apprised of all changes in New York-Presbyterian Hospital ChargeMaster program and can assist investigators in using the appropriate fees.

6.  Hispanic Translation Request Form (Preview form)
Use the Hispanic Translation Request Form to send documents that require translation, modification, or review by the Hispanic Translation Center. Click here to read instructions.

Hispanic Translation Center staff: click here to review requests.

7.  Investigational Device Exemption (IDE) Studies New
The Centers for Medicare and Medicaid Services (CMS) requires additional reporting as a condition for participating in an IDE study. The principal investigator is responsible for submitting to Empire Medicare Services all necessary information concerning the device and the study. Click here to read instructions.

Sponsor Documents
	Copies of all correspondence with the Sponsor, including the name(s) and telephone number(s) of any individual(s) from the Sponsor with whom the Investigator has been in contact, should be submitted to the CTO. Documents are to be mailed to the CTO mailing address.
CTO Review Process
	After receipt of relevant documents, the CTO will begin contract negotiations with the Industrial Sponsor. The contract process is usually completed within four weeks; previously negotiated contracts, issues regarding publication rights, indemnification and insurance, however, may impact the amount of time necessary to complete the contract. To prevent potential delay in processing the contract, the CTO needs to receive all contract documents as soon as possible from industrial sponsors. When the contract has been negotiated, a copy of the final draft of the contract will be sent to the Investigator with a Review & Return Sheet. The Investigator and the Department are asked to review the final draft, make comments (if applicable), and sign to indicate their approval. When the contract is signed by the investigator and IRB approval has been granted, two (2) copies of the Contract Agreement are signed by the HOSPITAL and the UNIVERSITY, and mailed to the industrial sponsor. The contract is fully executed after all parties involved in the agreement signs the contract. Copies of the contract will be archived by the CTO, General Counsel Office of Columbia University, and the General Counsel Office of New York-Presbyterian Hospital. After receipt of a fully executed copy of the Agreement, a University account is opened by the CTO, and post-award correspondence by industrial sponsors is directed to the CTO Finance-Accounts Receivable Team. All checks must be made to the Trustees of Columbia University and can only be endorsed by the University. Deposits are then transferred to the appropriate investigational accounts. Access to post-award fund distribution information is available for current contracts on the Investigator Overview page of this Web site.